Study on Nivolumab Alone or with Other Immunotherapy Drugs After Targeted Radiation for Advanced Esophagogastric Cancer
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials ID:NCT03610711
This clinical trial is testing the safety of using immune checkpoint inhibitors like nivolumab, alone or with another drug, after targeted radiation therapy in patients with advanced esophagogastric cancer that has returned or spread.
Patient Parameters
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Program Overview
This study is exploring the safety of using immune checkpoint inhibitors, specifically nivolumab alone or in combination with another drug called Relatlimib, after targeted radiation therapy in patients with advanced esophagogastric cancer. The study aims to see if this approach can enhance the effectiveness of nivolumab and overcome resistance to treatment. Patients will receive high-dose radiation to certain cancer sites, while one site will be left untreated for analysis. Approximately 21 patients will participate, with some receiving nivolumab alone and others receiving the combination treatment.
Description
This clinical trial is designed to test the safety and effectiveness of using nivolumab, an immune checkpoint inhibitor, alone or with another drug called Relatlimib, after targeted radiation therapy in patients with advanced esophagogastric cancer. The study is divided into two groups: one group will receive nivolumab alone, and the other will receive nivolumab plus Relatlimib. The goal is to see if this combination can improve treatment outcomes by enhancing the immune response against cancer cells.
Patients will undergo targeted high-dose radiation therapy to certain cancer sites, while one site will be left untreated to allow for tissue analysis. This untreated site will be biopsied before and after radiation to assess changes. If the untreated site does not respond to treatment, it may be irradiated later.
The study will enroll about 21 patients, with 6 in the nivolumab-only group and 15 in the combination group. Participants must have advanced esophagogastric cancer that has returned or spread and must not have received prior PD-1 therapy. The study will help determine if this approach can enhance the effectiveness of nivolumab and overcome resistance to treatment.
Eligibility Criteria
Inclusion Criteria
- Men and women aged 18 years or older.
- Diagnosed with esophageal or gastro-esophageal junction cancer or gastric cancer.
- Must provide a tumor biopsy sample for analysis.
- Have recurrent or Stage IV cancer and have declined first-line chemotherapy.
- For the Relatlimab group, must have a heart function test showing an ejection fraction of 50% or higher.
- Must be in good overall health with an ECOG performance status of 0 or 1.
- Must have adequate organ function, including specific blood cell counts and liver and kidney function.
- Must agree to use effective contraception during the study and for a specified period after the last dose of treatment.
- Must understand the study and be willing to sign an informed consent form.
Exclusion Criteria
- History of autoimmune disease or conditions requiring immune-suppressive medications, except for certain conditions like vitiligo.
- For the Relatlimab group, must not have high levels of certain heart enzymes or a history of heart inflammation.
- Must not have significant heart disease or recent heart attacks or strokes.
- Must not have ongoing need for systemic corticosteroids.
- Must not have had other cancers unless in complete remission for at least 2 years.
- Must not have known brain metastasis or a history of lung disease requiring oxygen.
- Must not have received vaccines within 4 weeks of starting the study.
- Must not have active infections or positive tests for Hepatitis B, C, or HIV.
- Must not be pregnant or nursing.
- Must not have allergies to study drugs.
- Must not have medical conditions that make the study treatment unsafe.
- Must not be incarcerated or detained for treatment of illness.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Johns Hopkins University | 21287 | Baltimore | Maryland |
| Alleghany Health Network | 15212 | Pittsburgh | Pennsylvania |
| Baylor University | 75246 | Dallas | Texas |
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